(171 days)
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Not Found
No
The summary describes a passive filter device with no mention of computational processing, algorithms, or learning capabilities.
No
The device is a filter for breathing circuits, removing microbiological and particulate matter, and provides heat and humidification, but it does not directly treat a disease or condition.
No
The device is a filter for breathing circuits, designed to remove microbiological and particulate matter. It provides heat and passive humidification. Its function is to modify the air patient breathes, not to gather information about the patient's health status.
No
The device description clearly describes a physical filter device with hydrophobic and hydrophilic filter media and a sonic welded housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Breathing Circuit Filter" intended to "remove microbiological and particulate matter from the gases in a breathing circuit." It also provides "Heat and passive humidification."
- Intended Use: The intended use is for use with "airway management systems including ventilators, respirators, and open flow systems" to filter inspired or expired gases.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to filter and humidify gases within the breathing circuit.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic device. It is a device used directly in the patient's breathing circuit for gas conditioning and filtration.
N/A
Intended Use / Indications for Use
Heat and passive humidification with filtration between patient and circuit. Designed for mechanical ventilation, anesthesia, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term healthcare facilities. Place at tracheostomy and/or on the inspiratory and/or expiratory side of the patient circuit. For single patient use only. For sale by or on the order of a physician.
Product codes
CAH
Device Description
The Series 1 Breathing Circuit Filter is a filter device designed for use with all ISO compliant airway management systems including ventilators, respirators and anesthesia circuitry.
The Series 1 Breathing Circuit Filter features include the following:
. Hydrophobic filter media
. Hydrophilic filter media
Sonic welded housing .
ISO compliant .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
tracheostomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, surgical centers, long term healthcare facilities, physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards.
Clinical Data: Not available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
FEB 2 2 2002
Image /page/0/Picture/2 description: The image shows a logo with a black triangle at the top, partially obscuring the letters "SPD" in a stylized font. The letters are also black and appear to be within an oval shape formed by multiple concentric lines. A horizontal line is at the bottom of the oval, providing a base for the entire design.
510 (K) Summary
Emergency Filtration Products, Inc. 4335 S. Industrial Road Suite 440 Las Vegas, NV 89103 702-798-4541 Telephone 702-798-4939 Fax Douglas K. Beplate, President & Chief Technology Officer 8/27/01 Date Prepared
| Trade Name: | Series 1 Breathing Circuit Filter |
|---|---|
| Common Name: | Breathing Circuit Filter |
| Classification Name: | Breathing circuit bacterial filter device |
| CAH, Class II | |
| 21CFR868.5260 |
Emergency Filtration Products, Inc. wishes to introduce to the market the Series 1 Breathing Circuit Filter, a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME.
The Series 1 Breathing Circuit Filter features include the following:
- . Hydrophobic filter media
- . Hydrophilic filter media
- Sonic welded housing .
- ISO compliant .
Intended Use:
The Series 1 Breathing Circuit Filter is a filter device designed for use with all ISO compliant airway management systems including ventilators, respirators and anesthesia circuitry.
Technological Characteristics: None
- Substantial Equivalence: Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards.
Clinical Data: Not available.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Mr. Douglas Beplate Emergency Filtration Products, Inc. 4335 South Industrial Road, Suite 440 Las Vegas, NV 89103
Re: K012958
Series 1 Breathing Circuit Filter Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: CAH Dated: November 27, 2001 Received: January 10, 2002
Dear Mr. Beplate:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) in the enactment date of the Medical Device Amendments, or to commerce proc to Hile) 20, 2017 11:15 pm accordance with the provisions of the Federal Food, Drug, de noos that have been that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mainer of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is exassinon (controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Douglas Beplate
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quind by of every of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatics noticated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K012958
Device Name: Breathing Circuit Filter
Indications For Use:
Heat and passive humidification with filtration between patient and circuit. Designed for Fical and passive namidines, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term mispirod or expired gasses to required utilizing anesthesiology or respiratory equipment. neathireare tacintros and the inspiratory and/or expiratory side of the patient circuit. Flace at hiacmine one on the mopinatese only. For sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012458
OR
Prescription Use
(Per 21 CFR 801.109)
Over the Counter Use __________
(Optional Format 1-2-96)